Donald Trump, AP

Fed­er­al judge scut­tles Trump's rule man­dat­ing drug prices in TV ads

The Trump ad­min­is­tra­tion has en­dured a set­back af­ter a fed­er­al court over­turned a rul­ing — oblig­at­ing drug man­u­fac­tur­ers to dis­close the list price of their ther­a­pies in tele­vi­sion ad­verts — hours be­fore it was stip­u­lat­ed to go in­to ef­fect.

In May, the HHS pub­lished a fi­nal rul­ing re­quir­ing drug­mak­ers to di­vulge the whole­sale ac­qui­si­tion cost— of a 30-day sup­ply of the drug — in tv ads in a bid to en­hance price trans­paren­cy in the Unit­ed States. The phar­ma­ceu­ti­cal in­dus­try has ve­he­ment­ly op­posed the rule, as­sert­ing that list prices are not what a typ­i­cal pa­tient in the Unit­ed States pays for treat­ment — that num­ber is typ­i­cal­ly de­ter­mined by the type of (or lack there­of) in­sur­ance cov­er­age, de­ductibles and out-of-pock­et costs. Al­though there is truth to that claim, the move was con­sid­ered sym­bol­ic in the Trump ad­min­is­tra­tion’s health­care agen­da to hold drug­mak­ers ac­count­able in a cli­mate where sky­rock­et­ing drug prices have in­censed Amer­i­cans on both sides of the aisle.

The suit, va­cat­ed by a DC fed­er­al judge on Mon­day, was brought on by a tri­fec­ta of drug­mak­ers: Mer­ck $MRK, Eli Lil­ly $LLY and Am­gen $AMGN, in ad­di­tion to the Na­tion­al As­so­ci­a­tion of Ad­ver­tis­ers, a trade as­so­ci­a­tion. They ar­gued that the rule eclipsed HHS’s au­thor­i­ty be­cause Con­gress “nei­ther ex­press­ly nor im­plied­ly grant­ed HHS the pow­er un­der the So­cial Se­cu­ri­ty Act to reg­u­late drug mar­ket­ing” and con­tend­ed that com­pelled speech vi­o­lat­ed the First Amend­ment.

The court agreed that the HHS does not have the statu­to­ry au­thor­i­ty to im­ple­ment the drug price dis­clo­sure rul­ing. Al­though the court does not take “any view on the wis­dom of re­quir­ing drug com­pa­nies to dis­close prices. That pol­i­cy very well could be an ef­fec­tive tool in halt­ing the ris­ing cost of pre­scrip­tion drugs. But no mat­ter how vex­ing the prob­lem of spi­ral­ing drug costs may be, HHS can­not do more than what Con­gress has au­tho­rized,” it con­clud­ed.

The Amer­i­can As­so­ci­a­tion of Re­tired Per­sons (AARP), a non-prof­it or­ga­ni­za­tion that ad­vo­cates for the el­der­ly, said it was dis­ap­point­ed by the court’s de­ci­sion.

Nan­cy Lea­Mond AARP

“High drug prices dis­pro­por­tion­ate­ly hurt old­er Amer­i­cans, par­tic­u­lar­ly Medicare Part D en­rollees who take an av­er­age of 4.5 pre­scrip­tion med­ica­tions each month. Most Medicare ben­e­fi­cia­ries live on fixed in­comes, with a me­di­an an­nu­al in­come of just over $26,000,” AARP ex­ec­u­tive VP and chief ad­vo­ca­cy and en­gage­ment of­fi­cer Nan­cy Lea­Mond said in a state­ment. “To­day’s rul­ing is a step back­ward in the bat­tle against sky­rock­et­ing drug prices and pro­vid­ing more in­for­ma­tion to con­sumers. Amer­i­cans should be trust­ed to eval­u­ate drug price in­for­ma­tion and dis­cuss any con­cerns with their health care providers.”

Trump has long lam­bast­ed the phar­ma­ceu­ti­cal in­dus­try for its pric­ing poli­cies. Af­ter cap­tur­ing the pres­i­den­cy, Trump pro­claimed drug­mak­ers were “get­ting away with mur­der.” His ad­min­is­tra­tion has since un­veiled a string of pro­pos­als to tem­per pric­ing, in­clud­ing one last year en­gi­neered to peg drug prices to over­seas rates for Medicare ben­e­fi­cia­ries.

As he mounts his re-elec­tion bid for 2020, Trump sug­gest­ed on Fri­day that an ex­ec­u­tive or­der is be­ing pre­pared to im­ple­ment a “fa­vored na­tions clause” to re­duce drug prices in the Unit­ed States, in con­ver­sa­tion with re­porters on the south lawn of the White House.

UP­DAT­ED: Bio­gen pulls the plug on prized IPF drug from $562M+ Stromedix buy­out

One of Biogen’s attempts to branch out has flopped as the biotech scraps a mid-stage program for idiopathic pulmonary fibrosis.

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Warts for the win: Aclar­is' lead drug clears piv­otal study

Aclaris Therapeutics has found a way to get rid of the warts and all.

The company — which earlier this month decided to focus on its arsenal of kinase inhibitors — on Monday unveiled positive data from a pivotal study testing its lead experimental drug for use in common warts.

The drug, A-101, was tested in a 502-patient study called THWART-2 — patients enrolled had one to six warts before qualifying for the trial. Patients either self-administered A-101 topical solution or a vehicle twice a week over a two-month period. A higher proportion of patients on the drug (a potent hydrogen peroxide topical solution) saw their warts disappear at day 60, versus the vehicle (p<0.0001) — meeting the main goal of the study.  Each secondary endpoint also emerged in favor of A-101, the company said.

Deborah Dunsire. Lundbeck

UP­DAT­ED: Deb­o­rah Dun­sire is pay­ing $2B for a chance to leap di­rect­ly in­to a block­buster show­down with a few of the world's biggest phar­ma gi­ants

A year after taking the reins as CEO of Lundbeck, Deborah Dunsire is making a bold bid to beef up the Danish biotech’s portfolio of drugs in what will likely be a direct leap into an intense rivalry with a group of giants now carving up a growing market for new migraine drugs.

Bright and early European time Monday morning the company announced that it will pay up to about $2 billion to buy Alder, a little biotech that is far along the path in developing a quarterly IV formulation of a CGRP drug aimed at cutting back the number of crippling migraines patients experience each month. In a followup call, Dunsire also noted that the company will likely need 200 to 250 reps for this marketing task on both sides of the Atlantic. And analysts were quick to note that the dealmaking at Lundbeck isn’t done, with another $2 billion to $3 billion available for more deals to beef up the pipeline.

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Tower Bridge in London [Shutterstock]

#UK­BIO19: Join GSK’s Hal Bar­ron and a group of top biotech ex­ecs for our 2nd an­nu­al biotech sum­mit in Lon­don

Over the past 10 years I’ve made a point of getting to know the Golden Triangle and the special role the UK biopharma industry plays there in drug development. The concentration of world class research institutes, some of the most accomplished scientists I’ve ever seen at work and a rising tide of global investment cash leaves an impression that there’s much, much more to come as biotech hubs are birthed and nurtured.

Charles Nichols, LSU School of Medicine

Could psy­che­delics tack­le the obe­si­ty cri­sis? A long­time re­searcher in the field says his lat­est mouse study sug­gests po­ten­tial

Psychedelics have experienced a renaissance in recent years amid a torrent of preclinical and clinical research suggesting it might provide a path to treat mood disorders conventional remedies have only scraped at. Now a preclinical trial from a young biotech suggests at least one psychedelic compound has effects beyond the mind, and — if you believe the still very, very early hype — could provide the first single remedy for some of the main complications of obesity.

It’s fi­nal­ly over: Bio­gen, Ei­sai scrap big Alzheimer’s PhI­I­Is af­ter a pre­dictable BACE cat­a­stro­phe rais­es safe­ty fears

Months after analysts and investors called on Biogen and Eisai to scrap their BACE drug for Alzheimer’s and move on in the wake of a string of late-stage failures and rising safety fears, the partners have called it quits. And they said they were dropping the drug — elenbecestat — after the independent monitoring board raised concerns about…safety.

We don’t know exactly what researchers found in this latest catastrophe, but the companies noted in their release that investigators had determined that the drug was flunking the risk/benefit analysis.

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Ac­celeron drops a de­vel­op­ment pro­gram as #2 drug fails to spark func­tion­al ben­e­fits in pa­tients with a rare neu­ro­mus­cu­lar ail­ment

Acceleron is scrapping a muscular dystrophy development program underway for its number 2 drug in the pipeline after pouring over some failed mid-stage secondary data.

Gone is the ACE-083 project in patients with facioscapulohumeral muscular dystrophy. Their drug hit the primary endpoint on building muscle but flopped on key secondaries for functional improvements in patients, which execs felt was vital to the drug’s success.

Scott Gottlieb, AP Images

Scott Got­tlieb has a new board po­si­tion to add to the re­sume — and this one is fo­cused on a fa­vorite sub­ject

Scott Gottlieb has another position to add to his lengthy roster of boards and advisory roles in the wake of his departure from the helm of the FDA.

He’ll be joining the advisory board of FasterCures, a think tank which former junk bond king Michael Milken set up to help drive more drugs to the market, looking to accelerate drug R&D. That’s a subject close to the heart of Gottlieb, who blazed a trail at the FDA focused on hustling up the process. That helped endear him to the industry, making him one of the most popular commissioners in FDA history.

It’s also likely to be a much less controversial post than his board position at Pfizer, which stirred criticism from Democratic presidential candidate Elizabeth Warren.

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Karyopharm lines up $150 mil­lion cash in­jec­tion to back con­tro­ver­sial drug launch

Karyopharm has entered into a royalty agreement worth up to $150 million to back the launch of their multiple myeloma drug — recently approved by the FDA over the objections of a majority of the agency’s outside experts.

The deal with HealthCare Royalty Partners, worth $75 million now and $75 million once certain regulatory and commercial milestones have been reached, will fund the commercialization of Karyopharm’s oral SINE compound Xpovio (selinexor) for patients with multiple myeloma who have already had at least four prior therapies. The money will help Karyopharm as it markets its newly approved drug and pushes through clinical trials testing the drug on refractory multiple myeloma patients with one to three therapies and patients with treatment-resistant diffuse large B-cell lymphoma. It will give Karyopharm a cushion through mid-2021.